- MGCD0103 Continues to Demonstrate Single-Agent Activity - 38% Response Rate, 43% Disease Control Rate and 86% Tumor Reduction Rate in Heavily-Pretreated Patients with Relapsed or Refractory Hodgkin Lymphoma
in 110mg Cohort - 67% Tumor Reduction Rate in Relapsed or Refractory Non-Hodgkin Lymphoma, Including an 18% Response Rate in Evaluable Diffuse Large B- cell Patients
ATLANTA, Dec. 9 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM) and MethylGene Inc. (TSX: MYG) today announced data from two ongoing Phase 2 studies with MGCD0103, the Companies' novel, isotype-selective histone deacetylase (HDAC) inhibitor, as a single-agent in the treatment of Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). Data from these studies were presented today at the 49th Annual Meeting and Exposition of the American Society of Hematology (ASH).
"These exploratory Phase 2 trials show meaningful activity of MGCD0103 in patients with differing types of lymphomas," said Patrick J. Mahaffy, president and chief executive officer of Pharmion. "This is important not only for the continuing development of MGCD0103 but also because it provides further evidence for the role of epigenetic therapies in the treatment of hematologic malignancies."
"Data from these most recent trials continue to demonstrate the single- agent potential for MGCD0103 in a patient population that currently has few effective therapeutic options," said Donald F. Corcoran, president and chief executive officer of MethylGene. "With our partners, we will continue to evaluate our current and near-term MGCD0103 clinical trials during 2008 with the goal to develop a potential registrational pathway."
Isotype Selective HDAC Inhibitor MGCD0103 Decreases Serum TARC Concentrations and Produces Clinical Responses in Heavily Pretreated Patients with Relapsed Classical Hodgkin lymphoma (HL), Abstract #2566 (Trial 010)
To date, 33 patients have been enrolled in this ongoing open-label Phase 2 study of refractory/relapsed classical Hodgkin lymphoma (HL). The majority of these patients have disease that has progressed following stem cell transplant as well as other subsequent therapies (100% of patients have undergone prior chemotherapy, 88% prior bone marrow or stem-cell transplant and 76% radiation treatment).
Of 21 evaluable patients who received the 110 mg starting dose, eight (38 percent) showed objective responses - two complete responses (CR) and six partial responses (PR). The overall disease control rate (CR+PR+stable disease (SD) greater than or equal to 6 cycles) was 43 percent. The median time to response was two cycles (one cycle equals 28 days). Tumor reductions were observed in 86 percent of patients who had CT scans and 57 percent of the patients experienced tumor shrinkages greater than 30 percent. The two CR patients have a preliminary progression-free survival (PFS) of 14 and 9 months at the time of analysis. The range of PFS from the responder group is 56 to greater than 396 days.
Adverse events (AE) associated with MGCD0103 administration of grade 3 or higher included pneumonia (15 percent), and thrombocytopenia (12 percent) and fatigue (9 percent).
Preliminary and early data from the 85 mg cohort revealed all five evaluable patients with tumor reduction of greater than or equal to 30 percent, including one PR and 2 near-PRs (49 percent and 45 percent tumor reduction). Three of these patients are ongoing in the 85 mg cohort. Enrollment in this cohort continues in order to gain additional experience at the 85 mg doses subsequent to planning potential future trials in this and other indications.
In summary, results from this ongoing trial suggest that single-agent MGCD0103 demonstrates significant anti-tumor activity in relapsed/refractory classical HL and is well-tolerated, with dose modifications used as necessary to manage toxicities. An 85 mg dose is continuing to be evaluated in this patient population.
Treatment of Relapsed or Refractory Lymphoma With the Oral Isotype- Selective Histone Deacetylase Inhibitor MGCD0103: Interim Results From a Phase 2 Study, Abstract 2571 (Trial 008)
To date, 50 patients have been treated in this Phase 2 study of MGCD0103 in non-Hodgkin lymphomas (NHL). Specific patient populations in this study included pre-treated patients with diffuse large B-cell lymphoma (DLBCL) (n=33) and follicular lymphoma (FL) (n=17). The majority of these patients have had prior treatment: 98 percent had chemotherapy, 96 percent had treatment with Rituximab(R), 49 percent had prior radiation treatment and 33 percent had stem-cell transplants.
Of the 34 patients evaluable for clinical response who had completed at least one cycle of treatment and had their disease reassessed, the objective response rate (CR+PR) was 15 percent in all patients and 18 percent in the DLBCL cohort. Responses include one complete response (CR) in a patient with DLBCL, and four partial responses (PR) observed in three DLBCL patients and one FL patient. Responses were observed within two to six cycles. Of the five patients who responded to treatment, the preliminary progression-free survival (PFS) ranged from 6 cycles to 12 cycles (one cycle is equal to 28 days).
Twenty-seven patients have been reassessed for tumor size by CT scan after initiation of treatment, with 18 patients (67 percent) demonstrating tumor reduction, including 12 patients (44 percent) with equal to or greater than 30 percent shrinkage and eight patients (30 percent) with greater than or equal to 40 percent shrinkage.
Among the 50 patients evaluable for safety at time of analysis, the most common drug-related toxicities grade 3 or higher were fatigue (14 percent), neutropenia (12 percent), thrombocytopenia (10 percent) and anemia (6 percent).
In summary, the results from this ongoing trial suggest that single-agent MGCD0103 demonstrates significant anti-cancer activity in relapsed and refractory NHL (DLCBL and FL subtypes) and has a manageable side effect profile.
MGCD0103 Presentations at ASH
-- Phase I/II study of MGCD0103, an Oral Isotype-Selective Histone Deacetylase (HDAC) Inhibitor, in Combination with 5-azacitidine in Higher-Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML) (Abstract #444) -- G. Garcia-Manero, M.D., MD Anderson Cancer Center; December 10, 2007, 2:45 pm; Georgia World Congress Center; Rooms A411-A412.
-- Poster #756-II: Isotype-selective HDAC Inhibitor MGCD0103 Decreases Serum TARC Concentrations and Produces Clinical Responses in Heavily Pretreated Patients with Relapsed Classical Hodgkin Lymphoma (HL) (Abstract #2566) -- A. Younes, M.D., MD Anderson Cancer Center; December 9, 2007; 10:30 am-7:00 pm; Presentation 5:00-7:00 pm; Georgia World Congress Center; Hall B4.
-- Poster #761-II: Treatment of Relapsed or Refractory Lymphoma with the Oral Isotype-Selective Histone Deacetylase (HDAC) Inhibitor MGCD0103: Interim Results from a Phase II study (Abstract #2571) -- A. Younes, M.D., MD Anderson Cancer Center; December 9, 2007;10:30 am-7:00 pm; Presentation 5:00-7:00 pm; Hall B4.
MGCD0103 is an orally-administered, isotype-selective HDAC inhibitor. The compound is currently in three Phase I/II clinical trials, in combination with Vidaza(R) for hematological malignances and with Gemzar(R) and Taxotere(R) in solid tumors; and in four Phase II monotherapy clinical trials in hematological malignancies.
About Hodgkin Lymphoma
Hodgkin lymphoma (HL) is a cancer of the lymphatic system that begins in the lymph nodes and progresses to other organs, including the lungs, liver, bone and bone marrow. It is characterized by the presence of Reed-Sternberg cells. Currently, there is no known cause of the disease, but epigenetic alterations including changes in histone acetylation, have been identified. In addition, the Epstein-Barr virus, HIV and familial history are known risk factors. The disease is slightly more prevalent in men than women, and the median age of diagnosis is 38.
About Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)
DLBCL and FL, the two most common types of non-Hodgkin lymphoma (NHL), are cancers of the body's B-lymphocytes. These cells mature in the bone marrow and then migrate to different areas of the body. DLBCL is a relatively aggressive form of lymphoma that can spread rapidly in the body. Treatment usually requires intensive combination chemotherapy and often the addition of rituximab. Autologous bone marrow transplantation is an option for patients who relapse, however this is only available for a select subset of patients. Retreatment with standard agents rarely results in cure for relapsed patients. FL is a less aggressive disease, but has a low cure rate and eventual progression with current therapeutic options. According to the American Cancer Society, there are approximately 59,000 new cases of non-Hodgkin lymphomas diagnosed each year in the U.S.; of these, approximately 18,000 are FL. DLBCL is the most common form of NHL lymphomas accounting for up to 30 percent of newly-diagnosed cases.
Pharmion is a leading global oncology company uniquely focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the U.S., Europe and additional international markets. Pharmion has a number of products on the market including the world's first approved epigenetic drug, Vidaza(R), a DNA demethylating agent. For additional information about Pharmion, please visit the company's website at http://www.pharmion.com.
MethylGene Inc. (TSX: MYG) is a publicly-traded biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer. The Company's lead product, MGCD0103, is an oral isotype-selective HDAC inhibitor presently in multiple clinical trials for solid tumors and hematological malignancies, including Phase 2 monotherapy and Phase 1/2 combination trials with Vidaza(R), Gemzar(R) and Taxotere(R). MGCD265 is an oral kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases. In addition, MethylGene has several preclinical programs: MGCD290 an HDAC inhibitor in combination with azoles for fungal infections; an HDAC program for Huntington's disease; and a sirtuins program for cancer. MethylGene's development and commercialization partners include Pharmion Corporation, Taiho Pharmaceutical and EnVivo Pharmaceuticals. Please visit our website at http://www.methylgene.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, including summary statements relating to the interim or preliminary results of clinical trials involving Vidaza and MGCD0103. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the final results to differ significantly from the results summarized by such statements. Preliminary results may not be confirmed upon final analysis of the detailed results of a trial and additional information relating to the safety, efficacy or tolerability of Vidaza and MGCD0103 may be discovered upon further analysis of clinical trial data and upon review and analysis of additional clinical trial data from this or other clinical trials. Additional risks and uncertainties relating to Pharmion and its business can be found in the "Risk Factors" section of Pharmion's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2007, its Annual Report on Form 10-K for the year ended December 31, 2006 and in Pharmion's other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and Pharmion undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise. Pharmion also disclaims any duty to comment upon or correct information that may be contained in reports published by the investment community.
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